NCT03670576

It's Not JUST Idiopathic Pulmonary Fibrosis Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of progression of fibrosis in ILD

Detailed description

The overall aims of this study are * Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology * To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease * Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression * Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients

Conditions

• Interstitial Lung Disease
• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
PROCEDURE	Optional Bronchoscopy	Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
OTHER	Quality of Life Questionnaires	MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
OTHER	Blood Samples for Biomarkers	a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
OTHER	Home Hand Held Spirometry	Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)

Timeline

• Start date: 2018-11-11
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2018-09-13
• Last updated: 2021-07-02

Locations

24 sites across 1 country: United Kingdom